MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-07-11 for ROD INTRODUCTION PLIERS FOR DUAL-OPENING IMPL F/6.0MM RODS 388.509 manufactured by Wrights Lane Synthes Usa Products Llc.
[114040285]
Reportedly there was no patient involvement. Date of event is unknown. Device is an instrument and is not implanted/explanted. Therapy date of concomitant device is unknown. A device history record review was performed for the subject device: part number: 388. 509, synthes lot number: 5164062, supplier lot number: a7pa03, release to warehouse date: 30-jan-2006, expiration date: n/a , manufactured by synthes (b)(4). No ncrs were generated during production. Service and repair evaluation: the customer reported the device was broken and cracked. The repair technician reported the tube had a piece broken off and missing, the ratchet was worn where it makes contact with the spring, the spring was worn, and the nut required replacement. Worn out parts is the reason for repair. The cause of the issue is unknown. The following parts were replaced: nut, ratchet, spring (set), dog point set screw, tube. The item was repaired per the inspection sheet, passed synthes final inspection on 25-jun-2018 and will be returned to the customer upon completion of the service and repair process. The evaluation was confirmed. The device was deemed serviceable and returned to the customer. No design or manufacturing issues were identified; therefore, it has been determined that no corrective and/or preventative action is proposed. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[114040286]
It was reported that during routine inspection on (b)(6) 2018, it was discovered that there were malfunctions on five (5) different instruments. The tube of two (2) rod introduction pliers for side-opening implants were discovered bent and the collar would not fit. In addition, it was also noted that the securing pin on the handle for hook/screw holder was starting to come out resulting to not accepting the holder screw. The rod introduction pliers for dual-opening implant was also noted to be broken or cracked. And the threaded holding sleeve for polyaxial screws was also found stripped and did not thread on the screw easily. There was no patient involvement. Concomitant devices reported: unknown collar (part # unknown, lot # unknown, quantity 1), unknown screw holder (part # unknown, lot # unknown, quantity 1), unknown polyaxial screw (part # unknown, lot # unknown, quantity 1) this is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2018-52819 |
| MDR Report Key | 7678989 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-07-11 |
| Date of Report | 2018-06-13 |
| Date Mfgr Received | 2018-06-13 |
| Date Added to Maude | 2018-07-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MICHAEL COTE |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | MONUMENT |
| Manufacturer Street | 1101 SYNTHES AVENUE |
| Manufacturer City | MONUMENT CO 80132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ROD INTRODUCTION PLIERS FOR DUAL-OPENING IMPL F/6.0MM RODS |
| Generic Name | PLIERS,SURGICAL |
| Product Code | HTC |
| Date Received | 2018-07-11 |
| Returned To Mfg | 2018-06-18 |
| Model Number | 388.509 |
| Catalog Number | 388.509 |
| Lot Number | 5164062 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WRIGHTS LANE SYNTHES USA PRODUCTS LLC |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-11 |